Table 2 Registration process of ANVISA vs. FDA
From: ANVISA: an introduction to a new regulatory agency with many challenges
ANVISA | FDA |
|---|---|
1. Pre-registration  a. Protocol for clinical study | Investigational New Drug (IND) |
2. Registration  a. Documents to be submitted  b. Protocol for the new drug  c. Protocol for import of the new drug | New Drug Application (NDA)/Biologics License Application (BLA) |
3. Post-registration  a. Change in registration, renewal of registration  b. History of Product Change (HMP) | a. Supplementary NDA/BLA b. Annual Report NDA/BLA |